Comparison of adenoma miss rate and adenoma detection rates between Endocuff Vission-assisted colonoscopy and conventional colonoscopy: a multicenter randomized trial (EXCEED study)

Comparison of adenoma miss rate and adenoma detection rates between Endocuff Vission-assisted colonoscopy and conventional colonoscopy: a multicenter randomized trial (EXCEED study) - EXCEED study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44323

Enrollment

708

Registered

2018-02-05

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer polyps

Interventions

Endocuff Vision- assisted colonoscopy

adenoma

colonoscopy

endocuff

polyp

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: aged between 40-75 referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy

Exclusion criteria

Exclusion criteria: - Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease - Personal history of colon cancer or polyposis syndrome - Familial adenomatous polyposis (FAP) - Known colitis or suspicion of colitis - Lower gastro-intestinal bleeding requiring acute intervention - Suspicion of large bowel obstruction or toxic megacolon - Prior incomplete colonsocopy (not including insufficient preparation) - ASA >3

Design outcomes

Primary

Measure	Time frame
Adenoma miss rate	—

Secondary

Measure	Time frame
Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain, World Health Organisation performance status), and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.	—

Measure

Time frame

Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain, World Health Organisation performance status), and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.

—

Countries

Greece

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)